European Medicines Agency seeks views on involvement of children and young people in Paediatric Committee

The paper describes the Agency's plans to develop a framework of interaction describing how the views of children and young people can be consulted as part of the Committee's work. This framework should:

define the expectations of the Committee from children and young people;

set out their role in the Committee's activities;

establish criteria for when they should be involved;

include a work plan for the practical aspects of their involvement, including the need to ensure their safety during any interactions with the Committee.

It also outlines the potential challenges involved in accessing the views of children from across Europe, including language barriers and variations in the ability of children to express themselves effectively.

The paper suggests that the Agency should use its existing network of European organisations representing patients and consumers to help find suitable children and young people wherever necessary. Many of these organisations already have experience working with this age group.

The PDCO is the committee at the Agency that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children. It was established in line with the Paediatric Regulation in 2007. This Regulation also states that the Agency has a responsibility to consult the views and opinions of children and young people in its activities.

The concept paper is open for comments until 19 November 2012. All comments should be sent to paediatrics@ema.europa.eu using the template provided. The PDCO will review all of the comments received by the end of the year.